FDA.reportPublic FDA data

AESCULAP

Primary DI
04038653039050
Brand
AESCULAP
Company
Aesculap AG
Model
EB063R
Catalog number
EB063R
Device description
"BAKES Gall Duct Dilator, 12 3/8"", (315 mm), diam. 3 mm, non-sterile, reusable"
Published
2020-04-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EZMDilator, esophageal (metal olive) gastro-urology

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EZMDilator, Esophageal (Metal Olive) Gastro-UrologyGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04038653039050PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04038653039050040386530390504038653039050

GMDN Terms#

Term, Definition table
TermDefinition
Common bile duct probeA hand-held manual surgical instrument designed as a slender rod made of flexible metal with a blunt bulbous tip, used for exploring the common bile duct, i.e., the union of the cystic and hepatic ducts. It is used in surgical procedures to explore and/or dilate strictures of the common duct. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)282-9000GUDID.BBMUS_Service@bbraun.com

Regulatory Flags#

DUNS number
315018218
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04038653042586AESCULAPET251RET251R2016-09-23
04046964227547AESCULAPGF058BGF058B2016-09-23
04038653148998AESCULAPDO706RDO706R2020-04-21
04038653105878AESCULAPLS059RLS059R2020-04-21
04038653106080AESCULAPLS099RLS099R2020-04-21
04038653034666AESCULAPDE419RDE419R2020-06-17
04038653034697AESCULAPDE422RDE422R2020-06-17
04038653105977AESCULAPLS084RLS084R2022-07-29
04038653199020AESCULAPXG105RXG105R2021-10-15
04038653199006AESCULAPXG103RXG103R2020-08-24
04038653199013AESCULAPXG104RXG104R2020-08-24
04038653460533AESCULAPXG106RXG106R2020-08-24
04046963000431AESCULAPXG107RXG107R2020-08-24
04046963000448AESCULAPXG108RXG108R2020-08-24
04046963611538AESCULAPXG126RXG126R2020-08-24
04038653109999AESCULAPND118RND118R2020-05-08
04038653110018AESCULAPND121RND121R2020-05-08
04038653110056AESCULAPND125RND125R2020-05-06
04038653201303PROCARTFR600RFR600R2020-04-22
04038653088690AESCULAPFK352RFK352R2020-04-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04038653039036AESCULAPAesculap AGEZM2016-09-23
04038653039043AESCULAPAesculap AGEZM2016-09-23
04038653039067AESCULAPAesculap AGEZM2016-09-23
04038653039074AESCULAPAesculap AGEZM2016-09-23
04038653039081AESCULAPAesculap AGEZM2016-09-23
04038653039098AESCULAPAesculap AGEZM2016-09-23
04038653039104AESCULAPAesculap AGEZM2016-09-23
04038653039111AESCULAPAesculap AGEZM2016-09-23
04038653039128AESCULAPAesculap AGEZM2016-09-23
04038653039135AESCULAPAesculap AGEZM2016-09-23
04038653039142AESCULAPAesculap AGEZM2016-09-23
04038653039159AESCULAPAesculap AGEZM2016-09-23
04038653226269AESCULAPAesculap AGEZM2016-09-23